의약품 관련 법령
Biomarker Qualification: Evidentiary Framework
작성자 | 관리자 | ||
---|---|---|---|
작성일 | 2018-12-13 | 조회수 | 1,174 |
국가정보 | 북 아메리카>미국 | ||
출처 | FDA | ||
원문 | https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM628118.pdf | ||
첨부파일 |
Biomarker Qualification: Evidentiary Framework
- 이전글 Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA
- 다음글 Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics